Evidence map›Paper›PMID 32641131›Full record

Observational studyBMC urology2020

Tolerability and safety of urotainer® polihexanide 0.02% in catheterized patients: a prospective cohort study.

Jürgen Pannek, Karel Everaert, Sandra Möhr, Will Vance, Frank Van der Aa, Jürg Kesselring

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02157415 (Prospective Cohort Study on the Tolerability and Safety of Uro-Tainer® Polihexanide 0.02% in Long-term Indwelling Catheterized Patients.), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02157415 naterminatednot on this map

Prospective Cohort Study on the Tolerability and Safety of Uro-Tainer® Polihexanide 0.02% in Long-term Indwelling Catheterized Patients.

TypeinterventionalSponsorB. Braun Ltd. Centre of Excellence Infection ControlRan2013 to 2018Enrolled33ConditionsComplications, Catheter, Urinary (Indwelling Catheter) (Suprapubic)ArmsUro-Tainer Polihexanide 0.02%
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. The In Vitro Ability ofPathogens (Basel, Switzerland) · 2021
    Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 6 institutions in 3 countries.

Jürgen PannekNeuro-Urology, Swiss Paraplegic Centre, Guido A. Zäch Strasse 1, CH - 6207, Nottwil, Switzerland. juergen.pannek@paraplegie.ch.ORCID http://orcid.org/0000-0002-9910-1295
Karel EveraertUrologie, Universitair Ziekenhuis, Gent, Belgium.
Sandra MöhrSchweizerisches Paraplegikerzentrum REHAB, Basel, Switzerland.
Will VanceUrology, Kliniken Beelitz GmbH, Beelitz-Heilstätten, Beelitz, Germany.
Frank Van der AaNational Multiple Sclerose Centrum, Melsbroek, Belgium.
Jürg KesselringDepartment of Neurology & Neurorehabilitation, Kliniken Valens, Valens, Switzerland.
Ghent University Hospital · BENational MS Center MelsbroekNeurologisches Fachkrankenhaus für Bewegungsstörungen/Parkinson · DESwiss Paraplegic Center · CHUniversity Hospital of Bern · CHValens Clinics · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with indwelling bladder catheters for > 2 weeks, bacterial colonization is inevitable, leading to urinary tract infections or encrustations with subsequent catheter blockage. Currently, bladder irrigations are the most frequently used prophylactic means, but the best solution remains yet to be determined. In vitro studies demonstrate that polihexanide is a promising option for catheter irrigation, but no data about safety and tolerability exist.

methodsIn a prospective observational study in patients with indwelling bladder catheter for > 2 weeks, a 0.02% polihexanide solution was used to rinse the catheter on five consecutive days. Adverse events, tolerability and vital signs were assessed before, during, after and at the end of the treatment period.

resultsThere was no serious adverse event in the study. A total of 28 adverse events (AEs) in 15 (46.88%) participants were experienced. Absolute changes in pain scores were not clinically relevant. No incidences of either flushing or sweating were found during instillation. Bladder spasms during instillation were reported in two cases during a single instillation. Mean pulse rates did not change by more than 3 beats per minute. Mean changes in body temperature did not exceed 0.12 °C. Clinically relevant changes in blood pressure were recorded for 3 patients.

conclusionsThis is the first study to demonstrate that a 0.02% polihexanide solution can safely be used for catheter irrigation.

trial registrationClinicalTrials.gov ( NCT02157415 ), June 6th, 2014.

Indexed as

BiguanidesCatheters, IndwellingDisinfectantsUrinary CathetersAgedCohort StudiesFemaleHumansMaleMiddle AgedProspective StudiesSolutionsTherapeutic IrrigationBiguanidesDisinfectantspolihexanideSolutionsBladder irrigationIndwelling catheterPolyhexanideUrinary tract infection

Identifiers

PMID32641131
PMCPMC7346619
OpenAlexW3041597135

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.